Why the government has tightened rules around pregabalin sales in India

Ministry of Health and Family Welfare has brought the drug Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, amid growing concerns over its misuse and unauthorised sale in several parts of the country.

The decision was notified through a Gazette notification published on May 20, following reports from multiple states regarding abuse of the medicine, particularly among young people.

Pregabalin is commonly prescribed for chronic pain, neuropathies, fibromyalgia and certain neurological conditions. However, health authorities said the medicine has increasingly been misused for its sedative, euphoric and dissociative effects.

Also Read | From coconut water to aam panna: AYUSH Ministry’s heatwave survival guide explained

The ministry also cited seizures of illegally stocked and unauthorisedly sold pregabalin in different regions of the country.

What changes under Schedule H1 rules

Prior to the new notification, pregabalin was categorised under Schedule H. With the new categorisation, pregabalin is expected to be more strictly controlled.

With regards to the Schedule H1 categorisation:

Pregabalin may only be sold when prescribed by a medical practitioner registered with the government

The pharmacy shall keep a separate record for each prescription and sale made

The manufacturer shall affix the label “Schedule H1 Drug Warning” to each unit sold

Violation is punishable under the provisions of the Drugs and Cosmetics Act of 1940

As per Health Ministry reports, the purpose of the new categorization is to improve accountability within the pharmaceutical supply chain and prevent trafficking of the drug.

Concerns over rising misuse

There has been an increased focus on pregabalin of late due to its potential for recreational use leading to intoxication.

There were minutes taken by Drugs Consultative Committee in their past deliberations indicating misuse of the pregabalin drug in high doses in states including the formulations in 150 mg and 300 mg capsules.

Also, cases of confiscation and distribution of the medication illegally had been reported in other states such as Punjab prior to the current ban.

Medical experts point out that medications like the pregabalin are prone to be misused owing to their ability to have an impact on the nervous system leading to relaxation when misused.

Also Read | Why official vehicle number 13 still scares Kerala politicians

Patients may face stricter purchase checks

While the move is aimed at preventing misuse, the tighter rules could also mean stricter verification procedures for patients who legitimately require pregabalin for medical treatment

Patients may now need to ensure prescriptions are up to date and pharmacies comply with additional documentation requirements during purchase.

The Health Ministry has advised manufacturers, distributors, retailers and pharmacists to ensure full compliance with the revised regulations.